NIM inclusion of anti-cancer vaccine may start with 9-14 year olds

Soon, the indigenously developed human-papillomavirus (HPV) vaccine, which prevents cancer-causing infections, may be part of the National Immunisation Mission (NIM). The standing technical sub-committee of the National Technical Advisory Group on Immunisation (NTAGI) has recommended inclusion of the vaccine in the central programme.

Sources say the vaccine may be initially given to girls between the age of 9 and 14 years. “Then it can also be expanded to include boys. With an India-made vaccine now, costs will not be so much of a constraint,” said a person close to the development.

Pune-based Serum Institute of India’s (SII) quadrivalent HPV vaccine was approved by the country’s drug regulator earlier this week. SII has not indicated the pricing yet, but said the launch will be towards the end of this calendar year. Doctors say the vaccine can be given to girls up to the age of 26 years, mostly before they become sexually active. 

At the moment, two HPV vaccines available in the private market are from foreign manufacturers — Gardasil, manufactured by Merck, and Cervarix by Glaxo Smithkline. SII’s entry into this space is expected to bring down the prices significantly. HPV vaccines are now available in the range of Rs 2,000-3,000 per dose.

The inclusion of this vaccine in the NIM is a significant step in reducing cervical cancer burden among women.

Cervical cancer ranks as the second most frequent cancer among women in India. About 5 per cent of women in the general population are estimated to harbour cervical HPV‐16/18 infection at a given time, and 83.2 per cent of invasive cervical cancers are attributed to HPVs 16 or 18.

HPV infection is now a well‐established cause of cervical cancer and HPV types 16 and 18 are types most frequent and responsible for about 70 percent of all cervical cancer cases worldwide.

India has 483.5 million women aged 15 years and older who are at risk of developing cervical cancer. Current estimates indicate that every year 123,907 women are diagnosed with cervical cancer and 77,348 die from the disease.

According to the 2011 census, around 114.8 million girls were between the age of 10 and 14 years. The numbers would be slightly different now, however, one can estimate around 100-120 million female children to be in the target age group for HPV vaccination under the NIM.

HPV types — 16, 18, 31, 33, 45, 52, 58 — are considered as high risk types as they can cause cancer. Type 6 and 11 are considered low risk types as they are not directly implicated in cancer causation. SII’s quadrivalent HPV vaccine works against type 6, 11, 16, 18. This means the vaccine gives protection against four different strains of HPV and can approximately give coverage against 90 per cent of the HPV prevalent in the developing world. 

Sampada Dessai, consultant, gynecologic cancer and robotic surgeon at PD Hinduja Hospital in Mumbai, said vaccination and screening are two important tools to prevent cervical cancer. Only 12-15 per cent of the cases of HPV infection and cervical cancer are detected in the early stages, as the cancer remains asymptomatic in the initial stages.

Home-made vax

• NTAGI actively considering inclusion of HPV vaccine in the NIM
• Serum Institute has not indicated the pricing yet, says will launch the vaccine by 2022-end
• NIM inclusion of HPV was held back due to high prices of foreign vaccines